Aplicação do modelo Lean Six Sigma no processo de controle de mudanças na fabricação de ingredientes farmacêuticos ativos para estudo clínicos

Abstract

This project aims to apply Lean Six Sigma concepts and methodologies, using the DMAIC tool. The focus is on improving the internal change control process of a pharmaceutical industry covering the manufacturing of active pharmaceutical ingredients (APIs) used in clinical studies. Data collected over a period of 2 years demonstrated that 52% of internal change controls records in the company’s electronic system, within the scope of the project, APIs used in clinical studies, were expired without an extension request. This situation can lead to observations in internal and external audits, quality deviations and regulatory issues. The use of the DMAIC tool allowed to identify some root causes of the process and confirmed that it was a long, complex, and laborious process. The interruption of the workflow, due to the several review cycles, and the lack of notification from the electronic system when change control is due to expire, were the two confirmed root causes. Also, the complexity of the process after data analysis made it possible to formulate improvement proposals to avoid human errors. Thus, the proposed new process allowed the harmonization, clarification, and separation of change control processes for clinical studies and commercial, allowing greater fluidity and reducing the risk of non-compliance. Furthermore, the cost of the new process proved to be around 3 times lower than the old one. The new process, once its effectiveness is proven, can be extended to other scopes of change control within the company such as drug product, packaging, supply chain, and others.